MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER LIGASURE PRECISE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	LS1200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blood Loss (2597); No Code Available (3191)
Date of Event	07/04/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Title parathyroid function following total thyroidectomy using energy devices source eur arch otorhinolaryngol, volume 273, 2016 (1905¿1911) date of publication: 4 july 2015.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the literature source, the aim of this study was to compare the effect of ligasure precise (lp) and non-medtronic scalpel (hs) in patients who had undergone total thyroidectomy, by highlighting the post-operative parathyroid function.A total of 201 consecutive patients for whom total thyroidectomy had been planned were prospectively classified into two groups.There were 104 patients in lp group and 97 patients in hs group.One patient of the lp group had post-operative bleeding that required re-operation.No further information available.

• Brand Name: LIGASURE PRECISE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 9195100
• Report Number: 1717344-2019-01347
• Device Sequence Number: 14103128
• Product Code: GEI
• UDI-Device Identifier: 10884524001463
• UDI-Public: 10884524001463
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K010010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: LS1200
• Device Catalogue Number: LS1200
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2019
• Initial Report FDA Received Date: 10/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 45 YR